Recombinant factor VII is associated with worse survival in complex cardiac surgical patients.

Background: Recombinant activated factor VII (rFVIIa) decreases requirements for allogeneic blood transfusion and chest reexploration in patients undergoing cardiac surgery. Whether rFVIIa increases the risk of postoperative adverse events is unclear. We tested whether rFVIIa administration was associated with increased mortality and neurologic and renal morbidity in patients undergoing cardiac surgery. Risk of thromboembolic complications and the dose-response of rFVIIa on mortality and morbidity were also evaluated.

Methods: Of 27,977 patients who had complex cardiac surgery, 164 patients (0.59%) received rFVIIa perioperatively. Using propensity-matching techniques, patients were matched to a maximum of 3 control patients. Patients who received rFVIIa were compared with control patients on risk of mortality, neurologic and renal morbidity, and thromboembolic complications, including a composite of myocardial infarction, pulmonary embolism, and deep venous thrombosis. A corresponding dose-response analysis using multivariable logistic regression was also performed.

Results: Propensity techniques successfully matched 144 patients (88%) with 359 control patients. Of patients who received rFVIIa, 40% experienced in-hospital mortality compared with 18% of control patients (odds ratio, 2.82; 98.3% confidence interval, 1.64 to 4.87; p<0.001). Furthermore, 31% of patients treated with rFVIIa versus 17% of control patients experienced renal morbidity (odds ratio, 2.07; 98.3% confidence interval, 1.19 to 3.62; p=0.002); however, neurologic morbidity and thromboembolic complications were not different among groups. High-dose rFVIIa (>60 μg/kg) did not increase the risk for mortality compared with treatment with low-dose rFVIIa (<60 μg/kg).

Conclusions: Administration of rFVIIa is associated with increased mortality and renal morbidity in patients undergoing cardiac surgery.